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Quality - Process Improver
Manati, PR · Biotech/PharmaceuticalDECISION MAKING
A. Describe the position's responsibility for taking action, making final decisions and developing recommendations. Limiting factors might include existing policies, procedures, laws, regulations, internal controls, etc.:
• The incumbent is responsible for the day-to-day decision making on technical matters related to troubleshooting, manufacturing investigations task items, CAPA’s, Change Controls, Stand Alone Actions.
• Takes immediate action and necessary decisions on manufacturing situations
• Responsibility of identifying, recommend and implement process and equipment modifications to improve process performance and maximize processes and equipment
• Decisions may have impact on compliance and cost initiatives
• Takes action to assure the manufacturing area is in cGMP’s compliance
B. Describe the nature of supervision received, the degree to which procedures, methods and goals are outlined by the supervisor, and the immediacy of supervision:
• Working relationship with unit’s members and unit Teams from other disciplines (Engineering/Maintenance, MS&T, QA/QC, LOSM, SC, etc.). Also works with minimum supervision, with periodic monitoring and review of results.
CONTACTS Describe the most important working relationships of this position. Include the frequency, level, and the purpose of contacts necessary for effective performance:
• Daily contact with site peers, management and staff to set and / or follow priorities driven by business needs.
• Regular interaction with internal / external auditors, government agencies, and other regulatory agencies or institutions.
• Works closely with Warehouse, Sterile and Non Sterile Operations Area Lead / Supervisors to improve current processes in order to optimize product efficiency/yields.
KNOWLEDGE / SKILL Describe the type and extent to which knowledge of a specific type is required to perform this job in a satisfactory manner. Where skills can be obtained through formal training / education and experience, list the type and amount of education and experience that would typically prepare an individual for this position:
• BS Degree in Science, Pharmacy and/or Engineering
• 6+ years of experience in a Parenteral Manufacturing operation facility
• Broad working experience with Change Controls/Change actions and CAPA
• Experience with validation protocols
• Strong technical writing and presentation skills
• Ability to interpret and analyze statistical data
• Knowledge in CGMP’s, OSHA, EPA and other regulatory standards
• Knowledge of computers applications (Microsoft Word, Excel, Power Point)
• Excellent leadership and interpersonal skills
• Team work oriented
• Excellent communications skills in Spanish /English
**Weil Group is proud to be an Equal Employment Opportunity Employer.**
A. Describe the position's responsibility for taking action, making final decisions and developing recommendations. Limiting factors might include existing policies, procedures, laws, regulations, internal controls, etc.:
• The incumbent is responsible for the day-to-day decision making on technical matters related to troubleshooting, manufacturing investigations task items, CAPA’s, Change Controls, Stand Alone Actions.
• Takes immediate action and necessary decisions on manufacturing situations
• Responsibility of identifying, recommend and implement process and equipment modifications to improve process performance and maximize processes and equipment
• Decisions may have impact on compliance and cost initiatives
• Takes action to assure the manufacturing area is in cGMP’s compliance
B. Describe the nature of supervision received, the degree to which procedures, methods and goals are outlined by the supervisor, and the immediacy of supervision:
• Working relationship with unit’s members and unit Teams from other disciplines (Engineering/Maintenance, MS&T, QA/QC, LOSM, SC, etc.). Also works with minimum supervision, with periodic monitoring and review of results.
CONTACTS Describe the most important working relationships of this position. Include the frequency, level, and the purpose of contacts necessary for effective performance:
• Daily contact with site peers, management and staff to set and / or follow priorities driven by business needs.
• Regular interaction with internal / external auditors, government agencies, and other regulatory agencies or institutions.
• Works closely with Warehouse, Sterile and Non Sterile Operations Area Lead / Supervisors to improve current processes in order to optimize product efficiency/yields.
KNOWLEDGE / SKILL Describe the type and extent to which knowledge of a specific type is required to perform this job in a satisfactory manner. Where skills can be obtained through formal training / education and experience, list the type and amount of education and experience that would typically prepare an individual for this position:
• BS Degree in Science, Pharmacy and/or Engineering
• 6+ years of experience in a Parenteral Manufacturing operation facility
• Broad working experience with Change Controls/Change actions and CAPA
• Experience with validation protocols
• Strong technical writing and presentation skills
• Ability to interpret and analyze statistical data
• Knowledge in CGMP’s, OSHA, EPA and other regulatory standards
• Knowledge of computers applications (Microsoft Word, Excel, Power Point)
• Excellent leadership and interpersonal skills
• Team work oriented
• Excellent communications skills in Spanish /English
**Weil Group is proud to be an Equal Employment Opportunity Employer.**